banner

Blog

Dec 17, 2023

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5

At its monthly meeting, EMA's safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table. Information on all topics discussed by the PRAC is available in the agenda below.

Procedure

Status

Update

Media enquiriesTel. +31 (0)88 781 8427E-mail: [email protected]

All other enquiriesplease submit your request via the online formFollow us on Twitter @EMA_News

Please do not include any personal data, such as your name or contact details. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency.

Safety signal assessments Periodic safety update reports Risk management plans Post-authorisation safety studies Referrals Summary safety reports Media enquiries All other enquiries do not include any personal data
SHARE